On November 24, 2006, the U.S. Food and Drug Administration (FDA) released a warning letter it sent to AstraZeneca PLC, makers of the anti-schizophrenia drug Seroquel. The letter states a professional sales aid for Seroquel used by the company "is false or misleading." The marketing piece is said to minimize the risk of taking Seroquel, as it has been linked to hyperglycemia, diabetes mellitus, neuroleptic malignant syndrome, tardive dyskinesia, and cataracts.

Seroquel has been approved for sale in the U.S. for the treatment of bipolar disorder and schizophrenia and is used for other off-label uses such as the treatment of insomnia and episodes related to post-traumatic stress disorder. Promotional materials that do not contain risk factor information misbrands the drug, in violation of the Federal Food, Drug and Cosmetic Act.

The sales material in question does not include information about the increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with atypical antipsychotics such as Seroquel. Hyperglycemia, or high blood sugar, is a classic symptom of diabetes mellitus, but can occur independently of diabetes.

The sales material also "fails to reveal the risk of" developing irreversible tardive dyskinesia on Seroquel, especially as the duration of treatment and total cumulative dose of Seroquel increases over time. Tardive dyskinesia is characterized by repetitive, involuntary movements of the body such as rapid eye blinking, grimacing, or movements of the arms, hands or legs.

AstraZeneca must remove the misleading materials by November 30, 2006, or face the possibility of regulatory FDA action, which can include seizure of products or injunction.

Sources: "AstraZeneca given FDA warning over 'misleading' material," MarketWatch, November 24, 2006; FDA Letter, November 24, 2006.